Method and apparatus for injecting a neurotoxin into a localized area

ABSTRACT

A syringe assembly for administration of a neurotoxin, the syringe assembly comprising: a syringe comprising: a clear syringe barrel with dosage markings completely encircling the clear syringe barrel; and a plunger having a plunger body and a clear inverted plunger tip; and a needle assembly comprising a needle and a sealing hub for removably attaching the needle assembly to the syringe, wherein the needle is approximately 0.15 inches to approximately 0.3 inches in length and has a gauge of approximately 27 gauge to approximately 35 gauge.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

This patent application claims benefit of pending prior U.S. ProvisionalPatent Application Ser. No. 62/571,364, filed Oct. 12, 2017 by LeslieTufts for IMPROVED NEEDLES FOR ADMINISTRATION OF LOCALIZED INJECTIONS(Attorney's Docket No. TUFTS-001/00US 34308/1), which patent applicationis hereby incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to syringe assemblies in general, and moreparticularly to methods and apparatus for injecting a neurotoxin into alocalized area.

BACKGROUND OF THE INVENTION

Botulinum toxin is a neurotoxic protein produced by a number ofdifferent bacterial species, including Clostridium botulinum. Althoughit is a powerful neurotoxin, botulinum has been developed for a numberof therapeutic and cosmetic uses, the most prominent being Botox®injections for cosmetic alteration of skin. Botox® reduces facialwrinkles and other fine lines in the skin by paralyzing muscles and iscommonly used for injection in the forehead and around the eyes. Botox®is also used to treat eye squints, excessive sweating, migraines andsome bladder and bowel disorders.

The botulinium toxin is typically stored in a powdered form in a glasscontainer with a rubber seal until it is time to administer thebotulinium toxin to a patient. At that time, saline is added to thebotulinium toxin powder to form a solution (i.e, to reconstitute thebotulinium toxin), and the solution is drawn into a syringe barrel forintramuscular injection through a needle.

While some clinicians manually remove the rubber seal with a bottleopener-type device to reconstitute the botulinium toxin, and then use asyringe to draw the botulinium toxin into the syringe barrel, this isnot a preferred method of loading a syringe since (i) it is moredifficult to draw the botulinium toxin into the syringe barrel when thecontainer cannot be flipped over because the top of the container isopen, and (ii) the process of opening the sealed container cancontaminate the botulinium toxin.

Accordingly, it is preferred to keep the rubber seal on the container,and then use a needle to pierce through the rubber seal and draw up thebotulinium toxin into the syringe barrel. In order to draw thebotulinium toxin solution into the syringe barrel, the needle must belong enough and thick enough to pierce through the rubber seal of theglass container holding the botulinium toxin solution without bendingthe needle. Conventional loading and delivery of botulinum toxin isgenerally accomplished with a syringe having a 27 to 32 gauge needlethat is typically 0.5 inches in length (but may be longer). This permitsthe needle to load the botulinium toxin into the syringe without bendingthe needle, however, the long length of the needle can penetrate toodeep into the unintended musculature of the patient.

A significant problem in the administration of botulinum toxin incosmetic procedures occurs when the needle penetrates too deeply intothe musculature. This is significant because the botulinium toxinspreads in a 1 cm radius around the injection site once it has beeninjected into the patient. It is highly important that the needle beinjected at the exact depth for treatment (i.e., at 0.25 inches) so asto prevent the botulinium toxin from acting on an unintended muscle. Forexample, pstosis (droopy eyelids) is a common side effect and is dueprimarily to migration of the botulinium toxin from its intended site tothe levator palpebrae superioris muscle. The levitator palpebrae muscleallows the eyelid to open fully, and the botulinum toxin can paralyzethis muscle, resulting in ptosis.

Another common treatment area for neurotoxins is the forehead. Ptosis ofthe brow can inadvertently occur here as well when a long needle is usedto deliver the botulinium toxin to the forehead. If the zygomaticusmajor and minor are injected improperly, paralysis of the side of theface can occur, and the patient appears as though he or she has suffereda stroke. Injecting too deeply into the orbicularis ori muscle mayinterfere with its function as well. Where injection is too deep intothe orbicularis ori muscle, the patient will experience difficultytalking, drinking and/or eating.

For the treatment of Crows Feet, injections are typically administeredsubdermally, however, when a long and large gauge needle is used, theneedle may penetrate beyond the desired subdermal injection site, whichmay result in diffusion of the neurotoxin outside of the desiredinjection site.

Clinicians attempt to limit excessive penetration of the needle andmigration of the neurotoxin by careful technique, which may includemanually controlling the depth of needle insertion, typically with theclinician's non-dominant hand (i.e., the hand not holding the syringe).However, with a typical 0.5 inch needle, there remains a significantrisk of ptosis and other unwanted side effects due to excessivepenetration of the needle into the site of injection.

Given the significant risk of ptosis and other side effects fromexcessive needle penetration, a need exists for a syringe assemblyhaving a needle which is long enough and strong enough to pierce throughthe rubber seal covering the glass container storing the botuliniumtoxin in order to draw up the botulinium toxin into the syringe barrel,but short enough and fine enough that the needle does not penetrate toodeep into the musculature of the patient during injection of thebotulinium toxin.

Furthermore, each time a needle passes through an object (e.g., therubber seal covering the glass container storing the botulinium toxin,the skin of the patient, etc.), the needle is dulled. Since a dullneedle causes more pain to a patient than a sharp needle, the needleshould be replaced once it becomes dull. However, a needle on aconventional syringe for neurotoxin injections cannot be removed fromthe syringe. Therefore, the entire syringe assembly (i.e., the syringeand the needle) needs to be discarded when a needle is dull and needs tobe replaced. Thus, there is also a need for a needle which can beremoved from a neurotoxin delivery syringe so that the entire syringeassembly does not need to be replaced when the needle needs to bereplaced.

In addition to the foregoing, conventional syringes used for Botox® andother neurotoxin injections have several features which can lead toinaccurate dosing of the neurotoxin.

More particularly, conventional syringes include a syringe barrel and aplunger disposed within the syringe barrel. The syringe barrel comprisesa hollow, elongated body having dosage markings on the exterior of thesyringe barrel. The plunger comprises a plunger body ending in a plungertip. Both the syringe barrel and the plunger of a conventional syringehave several shortcomings.

For one thing, with a conventional syringe, the plunger tip is flat,which can trap small amounts of the neurotoxin within the needle hub,which in turn prevents the appropriate dose of neurotoxin from beingcompletely injected into the patient and also wastes the neurotoxinproduct.

Furthermore, the plunger body and plunger tip have the same color, whichmakes it difficult to determine when the plunger tip is positioned atthe appropriate dosage marking on the syringe barrel. Additionally, thecolor of the colored plunger tip is often distracting to a clinicianand/or obstructs the clinician's view. This, in turn, may decrease thedosing accuracy.

Additionally, the dosage markings on the exterior of a conventionalsyringe barrel do not completely encircle the syringe barrel, thusmaking injecting the correct dosage of neurotoxin difficult as thedosage markings appear on only one side of the syringe barrel. Moreparticularly, when the needle is penetrating the skin of the patient,and the dosage markings are positioned on the side of the syringe barrelfacing away from the clinician, the clinician must rotate the syringeassembly until the clinician can read the dosage markings on the syringebarrel. Not only can this lead to inaccurate dosing of the neurotoxin,which can lead to ineffective treatment from the insufficient injectionof neurotoxin and/or deleterious side effects from the injection of toomuch neurotoxin, but the twisting of the syringe assembly while theneedle is positioned intramuscularly can also cause pain and discomfortto the patient as the clinician rotates the needle during injection ofthe neurotoxin.

The difficulty in determining how much neurotoxin is contained withinthe syringe barrel is enhanced because cosmetic neurotoxin injectionsare often given in very small amounts in multiple locations, thusrequiring visualization of dosage markings during injection of theneurotoxin and not just upon syringe loading.

Furthermore, a conventional syringe often has a small storage capacity(i.e., 0.5 cc). A small storage capacity requires use of more than onesyringe when injecting a neurotoxin into multiple sites on a patient,which leads to large amounts of waste and an increase in cost.

Thus, there is also a need for a new and improved syringe barrel andplunger for the local application of botulinum toxin and otherneurotoxins.

In addition to the foregoing, there is currently no standard thatgoverns the administration of neurotoxins to a patient, either withrespect to the syringe assembly used by clinicians or with respect tothe injection process. By way of example, some neurotoxin deliveryclinicians will use syringe assemblies that are typically used forinsulin delivery because those syringe assemblies have certainattributes that are useful in neurotoxin delivery, while otherclinicians use syringe assemblies that are used for other types ofinjections. Thus, there is also a need for a universal syringe assemblythat combines the preferences of each clinician into a single syringeassembly that can be consistently used by all clinicians for thedelivery of neurotoxins to a patient.

SUMMARY OF THE INVENTION

The present invention provides a new and improved syringe assembly forinjection of botulinum toxin and other neurotoxins or medicaments(sometimes also referred to herein as pharmaceutical compositions) intoa localized area in which over-penetration of the injection and/ormigration of the composition may have deleterious effects.

The syringe assembly of the present invention solves the problemsassociated with conventional syringe assemblies by:

(i) providing a syringe with a short removable needle, which limits thedepth that a needle penetrates during injection of the neurotoxin, andwhich can be easily removed from the syringe;

(ii) providing a syringe with a narrow gauge needle so as to increaseaccuracy of the placement of the injection, reduce trauma to thepatient, and reduce diffusion of the neurotoxin away from the injectionsite;

(iii) providing a plunger with an inverted plunger tip which reduces theamount of neurotoxin that remains in the syringe barrel after theplunger has passed through the syringe barrel to expel the neurotoxin;

(iv) providing a plunger having a plunger body with a clear plunger tipso as to provide a plunger tip which is visually distinct from theplunger body, whereby to enable a clinician to more accurately deliverthe appropriate dosage of neurotoxin to a patient, without distractingthe clinician with a colored plunger tip;

(v) providing a syringe barrel with dosage markings that completelyencircle the syringe barrel so that the dosage markings are no longerobstructed from the clinician's view at certain angles; and

(vi) providing a syringe with a larger capacity than conventionalsyringes.

In one preferred form of the present invention, there is provided asyringe assembly for administration of a neurotoxin, the syringeassembly comprising:

a syringe comprising:

-   -   a clear syringe barrel with dosage markings completely        encircling the clear syringe barrel; and    -   a plunger having a plunger body and a clear inverted plunger        tip; and

a needle assembly comprising a needle and a sealing hub for removablyattaching the needle assembly to the syringe, wherein the needle isapproximately 0.15 inches to approximately 0.3 inches in length and hasa gauge of approximately 27 gauge to approximately 35 gauge.

In another preferred form of the present invention, there is provided amethod for injecting a neurotoxin into a body of a patient, the methodcomprising:

providing a syringe assembly comprising:

-   -   a syringe comprising:        -   a clear syringe barrel with dosage markings completely            encircling the clear syringe barrel; and        -   a plunger having a plunger body and a clear inverted plunger            tip; and    -   a needle assembly comprising a needle and a sealing hub for        removably attaching the needle assembly to the syringe;

attaching a first needle assembly to the syringe assembly;

passing the needle into a container of neurotoxin and drawing theneurotoxin into the syringe assembly;

removing the first needle assembly from the syringe assembly;

attaching a second needle assembly to the syringe assembly, wherein theneedle of the second needle assembly is shorter and narrower than theneedle of the first needle assembly; and

delivering the neurotoxin into the body of a patient.

In yet another preferred form of the present invention, there isprovided a method for injecting a neurotoxin into a body of a patient,the method comprising:

providing a syringe assembly comprising:

-   -   a syringe comprising:        -   a clear syringe barrel with dosage markings completely            encircling the clear syringe barrel; and        -   a plunger having a plunger body and a clear inverted plunger            tip; and    -   a needle assembly comprising a needle and a sealing hub for        removably attaching the needle assembly to the syringe;

attaching a first needle assembly to the syringe assembly, wherein theneedle is approximately 0.5 inches to approximately 1.0 inches in lengthand has a gauge of approximately 20 gauge to approximately 27 gauge;

passing the needle into a container of neurotoxin and drawing theneurotoxin into the syringe assembly;

removing the first needle assembly from the syringe assembly;

attaching a second needle assembly to the syringe assembly, wherein theneedle is approximately 0.15 inches to approximately 0.3 inches inlength and has a gauge of approximately 27 gauge to approximately 35gauge; and

delivering the neurotoxin into the body of a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIG. 1 is a schematic view showing a syringe assembly according to thepresent invention;

FIGS. 2-4 are schematic views showing the syringe assembly of thepresent invention with dosage markings extending around the entirecircumference of the syringe barrel;

FIG. 5 is a schematic view showing the syringe assembly of the presentinvention with an alternative presentation of dosage markings; and

FIG. 6 is a schematic view of the syringe assembly of the presentinvention with an alternative plunger.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides new and improved syringe assemblies forinjection of botulinum toxin and other neurotoxins or medicaments(sometimes also referred to herein as pharmaceutical compositions) intoa localized area in which over-penetration of the injection and/ormigration of the pharmaceutical composition may have deleteriouseffects.

FIG. 1 shows an exemplary syringe assembly 5 according to the presentinvention. More particularly, syringe assembly 5 comprises a syringe 10and a needle assembly 15. The needle assembly is removably attached tothe distal end of syringe 10 and comprises a needle for use in theinjection of neurotoxins (e.g., Botox®, Dysport® and Xeomin®) to apatient, as will be discussed in further detail below.

Syringe 10 generally comprises a syringe barrel 20 and a plunger 25disposed within the syringe barrel. Syringe barrel 20 comprises a clear,hollow, elongated body having dosage markings 30 disposed on theexterior of the syringe barrel. Dosage markings 30 indicate the amountof neurotoxin contained within syringe barrel 20.

Plunger 25 comprises a plunger body 35 having an inverted plunger tip40. Inverted plunger tip 40 is narrower than plunger body 35 and isspecifically shaped to fit within needle assembly 15 so as to ensurethat the neurotoxin is completely evacuated from syringe 10 and nottrapped in needle assembly 15 (which can happen with a flat or squareplunger tip).

In a preferred form of the invention, plunger body 35 is clear or opaqueand plunger tip 40 is clear.

A thick dark marking 60 appears at the distal end of plunger body 35 inthe area where plunger body 35 meets plunger tip 40 (i.e., junction 45)so that the end of plunger body 35 can be easily seen by a clinician asthe plunger moves past the dosage markings on the syringe barrel.Marking 60 may be formed integral with plunger body 35 or plunger tip40, or marking 60 may be a circular band or ring surrounding plungerbody 35 at junction 45. Marking 60 is preferably a dark color (e.g.,black) so as to be visually distinct from clear or opaque plunger body35 and clear plunger tip 40. When marking 60 is aligned with a dosagemarking 30 on syringe barrel 20, a clinician can determine the amount ofneurotoxin contained within syringe barrel 20 and/or determine theamount of neurotoxin that has been delivered to the patient. Sincemarking 60 is visually distinct on plunger 25, it is easier for aclinician to visually control the amount of neurotoxin in syringe barrel20, which significantly improves dosage accuracy.

Furthermore, the clear plunger tip also increases dosing accuracy as itis not distracting or obstructive to a clinician's view when performingan injection.

Needle assembly 15 comprises a needle 50 and a sealing hub 55 forattaching needle 50 to the distal end of syringe 10.

Needle 50 may be about 0.15 inches to about 0.30 inches in length andabout 27 gauge to about 35 gauge in diameter. In one preferred form ofthe invention, needle 50 is approximately 0.25 inches in length andapproximately 33 gauge in diameter. Preferably, needle 50 is beveled forease of penetration into the intramuscular injection site of thepatient.

The 0.25 inch needle allows for precise placement of the needle in theintended injection site and minimizes deep penetration and consequentdiffusion of neurotoxin away from the intended site of injection. Inother words, needle 50 is long enough to provide sufficient penetrationinto an intended intramuscular site for localized delivery of aneurotoxin, but not so long as to risk over-penetration of the needleinto an unintended intrasmuscular site. Thus, needle 50 is useful forthe administration of neurotoxins into the body of the patient in whichlocalized injection and limited diffusion is important in order tominimize adverse side effects.

Sealing hub 55 is preferably formed integral with needle 50 and may beattached to the distal end of syringe 10 via a friction fit or by ascrew mechanism, or in other ways well known to those skilled in the art(e.g., via a Luer Lock mechanism). Sealing hub 55 permits a needle to beremoved from, and/or attached to, syringe 10. This is significantbecause it permits a longer, wider gauge needle (e.g., 0.5 inches orlonger and 20 gauge in diameter) to be attached to syringe 10 and usedto draw neurotoxin from a storage source into the syringe barrel (or toreconstitute the neurotoxin) and then the longer, wider needle can beremoved from the syringe so that the shorter, narrower needle of thepresent invention may be used to inject the neurotoxin into the patient.

Looking next at FIGS. 2-4, an alternative syringe barrel is shown. Inthis form of the present invention, dosage markings 30 extend around theentire circumference (i.e., 360 degrees) of clear syringe barrel 20 soas to completely encircle the syringe barrel.

In a preferred embodiment, syringe barrel 20 can hold 1.0 cc ofneurotoxin, with syringe barrel 20 being clearly marked in 0.1 ccincrements from the distal end of the syringe barrel to the proximal endof the syringe barrel (i.e., the area of the syringe that is proximal towhere the plunger is depressed). Typically, the barrel is marked by 0.1cc increments beginning with 0.0 cc at the distal end of the syringebarrel and ending at 1.0 cc at the proximal end of the syringe barrel.

The dosage markings are marked in a color (e.g., black) that stands outon the clear syringe barrel. In addition to the 0.1 cc incrementmarkings, there are ten 0.01 cc markings between each 0.1 cc marking,with each line marked in black between 0 and 0.1 cc representing 0.01cc. Preferably, the 0.05 cc level is marked in bold and/or with a largerdemarcation. This bolder demarcation of the 0.05 cc level markingbetween each 0.1 cc measurement continues until 1.0 cc is reached.

As shown in FIG. 4, dosage markings 30 are darkest black at 0.1 ccincrements, slightly lighter black at 0.05 cc increments, and lightestblack at 0.01 cc increments.

Alternatively, dosage markings 30 can be orange instead of black. Inthis embodiment, the darkest orange is at 0.1 cc increments, slightlylighter orange at 0.05 cc increments and lightest orange at 0.01increments. Whether black or orange (or any other color) dosage markings30 are used on clear syringe barrel 20, plunger tip 40 should be clearand marking 60 at junction 45 should be dark black (or any other darkcolor) to contrast against the dosage markings and/or syringe barrel 20.

In this way, the syringe assembly of the present invention provides asyringe barrel with highly visible and unobstructed calibrations thatencircle the entire circumference of the syringe barrel. This enablesthe clinician to clearly see the dosage markings regardless of how thesyringe is held.

By way of example but not limitation, when neurotoxins are injected intoa patient to treat Crows Feet, a needle having a beveled tip istypically used, and it is preferable to have the bevel side of theneedle tip facing up during the injection. Having to position a needleat a certain angle is complicated when the dosage markings are only onone side of the syringe barrel because a clinician would be unable tosee the dosage marking if the markings were on the opposite side of thesyringe barrel. However, by providing a syringe assembly with the dosagemarkings encircling the entire syringe barrel, a clinician does not haveto worry whether or not the dosage markings will be visible when thebevel of the needle tip is facing up, since the dosage markings willalways be visible at any angle.

Thus, the provision of a syringe barrel having dosage markings thatcompletely encircle the syringe barrel is a significant improvement overconventional syringe assemblies because the dosage markings are nowvisible to the clinician along the entire circumference of the syringebarrel, regardless of how the syringe is held. This significantlyimproves the dosing accuracy since a clinician no longer has to turn thesyringe in order to read the dosage markings on one side of the syringein order to determine the amount of neurotoxin contained within thesyringe barrel. This also leads to less discomfort for the patient asturning the needle once it has been injected causes unnecessary traumato the patient.

Looking now at FIG. 5, an alternative presentation of dosage markings isprovided on syringe barrel 20. In this embodiment, the syringe barrel issimilar to the syringe barrel of FIGS. 1-4, but the cc (or mL) lineincrements have been replaced with units ranging from 1 unit to 40units. More particularly, the first line at the distal end of thesyringe barrel refers to 1 unit, and the proximal end of the syringebarrel is labeled 40 units, with each line marking increasing by 1 unitbetween 1 unit and 40 units, and with each line marking extending aroundthe entire circumference of the syringe barrel. While the units areshown in black, it is important to note that any color which is visibleon the syringe barrel may be used (e.g., orange). It is also importantto note that there is no need to vary the shading of the colors sinceeach line marking equals 1 unit.

Marking the syringe barrel with units instead of cc's or mL's issignificant because Botox® dosing is typically provided in units, witheach 5 units of Botox® equaling 0.1 cc. When the dosage markings on thesyringe barrel are presented as cc's or mL's, a clinician first has tocalculate the number of cc's that correspond to the number of units tobe injected for each dose of Botox® (e.g., if 10 units are to beinjected, the clinician must convert the 10 units into cc's beforedelivery to the patient, rather than simply delivering 10 units ofBotox® to the patient). By replacing the cc markings with units, aclinician can skip the extra step of calculating the number of cc's perunit of Botox®—a clinician simply injects the number of units suggestedfor the Botox® injection.

The syringe assembly of the present invention is generally used asfollows:

(i) the syringe assembly is fitted with a longer/wider gauge needle, andthe longer/wider gauge needle is used to draw neurotoxin from a storagecontainer and into the syringe;

(ii) the longer/wider gauge needle is removed from the syringe assemblyand replaced with a shorter/narrower gauge needle;

(iii) the syringe assembly with the shorter/narrower gauge needle isused to administer neurotoxin to a patient;

(iv) the shorter/narrower gauge needle is replaced as needed duringadministration of the neurotoxin into multiple injection sites; and

(v) the syringe assembly is discarded once the procedure is completed.

More particularly, when a neurotoxin is to be administered into alocalized area of a patient, syringe assembly 5 may be used. First, anappropriate size syringe 10 (e.g., 1.0 cc) is chosen and sealing hub 55is used to secure an appropriately sized first needle 50 to the distalend of syringe 10. First needle 50 may be long and wide (e.g., 0.5inches and 20 gauge) so as to draw neurotoxin from a storage containerand into syringe 10 quickly and/or to allow for reconstitution of theneurotoxin in syringe 10 (e.g., diluting 100 units of the neurotoxin,Botox®, with 2.5 cc of bacteriostatic saline). Once the desired amountof neurotoxin is drawn into syringe 10, first needle 50 is removed fromsyringe 10. It should be appreciated that dosage markings 30 (incombination with marking 60 at junction 45) are used to visuallyindicate to the user when the desired amount of neurotoxin is in syringe10.

Next, a second needle 50 which has a shorter length and narrower gauge(e.g., 0.25 inches and 33 gauge) than first needle 50 is connected tosyringe 10 via sealing hub 55. It should be appreciated that secondneedle 50 is long enough to provide sufficient penetration into anintramuscular site for localized delivery of the neurotoxin, but not solong as to risk over-penetration of the needle into an unintendedintramuscular site, and second needle 50 is narrower than a conventionalneurotoxin injection needle so as to allow for more precise placement ofthe injection, decreased diffusion of the neurotoxin and decreased painto the patient. Once second needle 50 has been connected to syringe 10,syringe assembly 5 is ready for use on a patient.

Second needle 50 is inserted through the skin of a patient at a desiredlocation and plunger 25 is pushed to inject a controlled amount ofneurotoxin into the patient. As neurotoxin is injected into the patientusing syringe assembly 5, dosage markings 30 (in combination withmarking 60 at junction 45) are used to visually indicate to the user theamount of neurotoxin which has been injected into the patient at eachlocalized site of injection. The distinct contrast of marking 60 atjunction 45 against the clear syringe barrel 20 ensures that the usercan readily take note of dosage amounts by checking where marking 60aligns with dosage markings 30 during and/or after an injection (e.g.,marking 60 aligns with the 0.9 cc dosage marking before pushing plunger25, and then marking 60 aligns with the 0.8 cc dosage marking afterpushing plunger 25 to show that 0.1 cc (i.e., 5 units) of neurotoxin hasbeen injected into the patient).

During the procedure, needle 50 may be replaced as necessary as the userof syringe assembly 5 moves between various injection sites. Thisensures that the needle remains sharp for each injection. It should beappreciated that replacing needle 50 between injections increasescomfort for the patient throughout a procedure. Once the procedure iscompleted, syringe assembly 5 is discarded. It should also beappreciated that syringe assembly 5 contains very little to no waste ofneurotoxin when discarded due to inverted plunger tip 40 of plunger 25not allowing any neurotoxin to be trapped in sealing hub 55 of needleassembly 35. In this way, the use of syringe assembly 5 also decreasesthe expense of many localized injection procedures.

It should be appreciated that modifications can be made to the syringeassembly of the present invention while still remaining within the scopeof the present invention. By way of example but not limitation, andlooking now at FIG. 6, an alternative plunger 25A is shown.

In FIG. 6, plunger 25A is similar to the plunger 25 discussed above,however, plunger body 35A is colored (instead of clear or opaque).Unlike conventional plunger tips (which typically are the same color asthe plunger body), the clear inverted plunger tip 40A of FIG. 6 is adifferent color than plunger body 35A, whereby the point of color changeprovides a junction 45A which can be easily seen by a clinician as theplunger moves past the dosage markings on the syringe barrel.

When junction 45A is aligned with a dosage marking 30 on syringe barrel20, a clinician can determine the amount of neurotoxin contained withinsyringe barrel 20 and/or determine the amount of neurotoxin that hasbeen delivered to the patient. Since junction 45A is visually distincton plunger 25, a clinician can visually control the amount of neurotoxinin syringe barrel 20, which significantly improves dosage accuracy.

Whether plunger body 35 is clear, opaque or colored, it is important tonote that plunger body 35 is clear, opaque or colored so that theplunger body is distinct in the clear syringe barrel, and the plungertip is clear so that the clinician can visually distinguish between theend of the plunger body and the plunger tip so that it will be easierfor a clinician to align the end of the plunger body with theappropriate dosage marking on syringe barrel 20. The clear plunger tipof the present invention is also less distracting than plungers whichare one color with no marking between the plunger body and the plungertip.

In summary, the present invention provides a new and improved syringeassembly for neurotoxin injections having a syringe and a removableneedle assembly, wherein the syringe comprises (i) a clear syringebarrel capable of holding 1.0 cc and including dosage markings whichcompletely encircle the syringe barrel, and (ii) a plunger, wherein theplunger comprises a clear (or opaque) plunger body and a clear invertedplunger tip, with a marking at the distal end of the plunger body tomark the end of the plunger body, thereby clearly showing where to alignthe plunger body with the dosage marking on the syringe barrel, andfurther wherein the needle used for the neurotoxin injection is shortand narrow (e.g., a 0.25 inch, 33 gauge needle).

Significantly, all of these features are combined into a single syringeassembly so as to provide a number of improvements over a conventionalsyringe assembly.

More particularly, the use of a short needle (i.e., 0.25 inch) having anarrow gauge (i.e., 33 gauge) allows for the precise placement of theneedle in the body of a patient, thereby minimizing the potential forover-penetration and/or diffusion of the neurotoxin away from theintended site of injections. This in turn increases patient comfort andcauses less bruising during injection and decreases the risk of unwantedside effects in a patient.

It should be appreciated that the removable needle assembly of thepresent invention allows a clinician to draw neurotoxin into the syringewith one size of needle attached to the syringe, and then remove andreplace the needle with another size needle. In this way, a clinicianmay draw neurotoxin into the syringe barrel with a larger needle so asto fill the syringe faster, and then remove the larger needle andreplace the larger needle with a smaller needle (i.e., the 33 gauge,0.25 inch needle of the present invention) more appropriate for theprocedure to be conducted on a patient.

Furthermore, by attaching the needle to the syringe with a removableneedle tip, a dull needle can be removed from the syringe and replacedwith a sharp needle without having to discard the entire syringeassembly (i.e., the syringe and the needle), which reduces waste andtime. A needle attached to the syringe by a removable needle tip allowsthe needle to be changed multiple times as different sites are injected,which in turn leads to less pain for the patient. Additionally, where aprocedure requires multiple injections using the same syringe, thesmaller size needle may be replaced as needed (e.g., if the needledulls) in order to increase patient comfort and provide more accuratedosing from the fine sharp tip of the narrow gauge needle.

It should also be appreciated that the provision of a syringe barrelwith non-obstructed calibrations (i.e., dosage markings that completelyencircle the syringe barrel) is a significant improvement overconventional syringe assemblies because the dosage markings are nowvisible to the clinician along the entire circumference of the syringebarrel. This significantly improves the dosing accuracy since aclinician no longer has to turn the syringe in order to read the dosagemarkings on one side of the syringe in order to determine the amount ofneurotoxin contained within the syringe barrel. This, in turn, alsoleads to less discomfort for the patient.

It should be further appreciated that the clear inverted plunger tipallows for complete expulsion of neurotoxin from syringe 10, whichreduces waste and decreases costs and is also less distracting for theclinician.

It is important to note that any appropriately sized syringe may be usedin connection with the present invention, as long as the syringe iscompatible with different size (i.e., gauge and length) needles.However, by providing a syringe with a larger capacity than conventionalsyringes, the syringe can accommodate many units of neurotoxin whichwill enable one syringe to be used for injecting the neurotoxin intomultiples sites. This will also reduce waste and costs associated withneurotoxic delivery.

Each of the improvements provided by the syringe assembly of the presentinvention are significant because there is currently no antidote for theadverse side effects associated with inaccurate dosing or diffusion ofthe neurotoxin from the intended injection site. The better accuracyprovided by the syringe assembly of the present invention will reduceside effects while also working to establish a universal syringeassembly that can be used by all clinicians delivering neurotoxins topatients.

Modifications

While the present invention has been described in terms of certainexemplary preferred embodiments, it will be readily understood andappreciated by those skilled in the art that it is not so limited, andthat many additions, deletions and modifications may be made to thepreferred embodiments discussed above while remaining within the scopeof the present invention.

1.-23. (canceled)
 24. A syringe assembly for administration of aneurotoxin, the syringe assembly comprising: a syringe comprising: aclear syringe barrel with dosage markings completely encircling theclear syringe barrel; and a plunger having a plunger body and aninverted plunger tip; and a needle assembly comprising a needle and asealing hub for removably attaching the needle assembly to the syringe,wherein the needle is approximately 0.15 inches to approximately 0.3inches in length and has a gauge of approximately 27 gauge toapproximately 35 gauge.
 25. The syringe assembly according to claim 24,wherein the syringe is a 1.0 cc syringe.
 26. The syringe assemblyaccording to claim 24, wherein the dosage markings are cc markings. 27.The syringe assembly according to claim 24, wherein the dosage markingsare unit markings.
 28. The syringe assembly according to claim 24,wherein the unit markings are derived based on dilution of a medicamentto be delivered by said syringe assembly.
 29. The syringe assemblyaccording to claim 24, wherein the dosage markings are both unitmarkings and cc markings.
 30. The syringe assembly according to claim24, wherein said inverted tip is clear.
 31. The syringe assemblyaccording to claim 24, wherein the plunger body is clear.
 32. Thesyringe assembly according to claim 24, wherein the plunger body isopaque.
 33. The syringe assembly according to claim 24, wherein theplunger body and inverted tip are different colors.
 34. The syringeassembly according to claim 24, wherein the needle is 0.25 inches inlength.
 35. The syringe assembly according to claim 24, wherein theneedle is 33 gauge.
 36. The syringe assembly according to claim 24,wherein a marking is disposed between the plunger body and the invertedplunger tip to enhance visual distinction between the plunger body andthe inverted plunger tip.
 37. The syringe assembly according to claim24, wherein the neurotoxin is botulinum toxin.
 38. The syringe assemblyaccording to claim 24, wherein thickness of said dosage markings isgraduated from lowest dosage to highest dosage.
 39. The syringe assemblyaccording to claim 24, wherein darkness of said dosage markings isgraduated from lowest dosage to highest dosage.